Sterimed 0284-2
Sterimed 0284-2 is a Class II device made by Sterimed, Inc., cleared under FDA 510(k) K853044 on 1 Nov 1985 and listed in FDA GUDID since 18 Sep 2017 (UDI-DI 00867878000415), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00867878000415 | Date18 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK853044 | Date1 Nov 1985 | StatusActive |
Official records
- AccessGUDID record 00867878000415
- FDA 510(k) database K853044
Across registries
- FDA 510(k) K853044 decided 1 Nov 1985 Active
- FDA GUDID UDI-DI 00867878000415 listed 18 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K853044
- Listed FDA GUDID 00867878000415
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sterimed
- Generic name
- X-ray system cover
- Model / reference
- 0284-2
- Primary DI / UDI-DI
- 00867878000415
- 510(k) Number
- FDA product code
- IZI
- GMDN term
- X-ray system cover
- Device class
- Class II
- Regulation number
- 892.1600
- GUDID distribution status
- In Commercial Distribution
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